Z-0034-2022 Class II Terminated
FDA device recall Z-0034-2022 was initiated by Flower Orthopedics Corporation on September 3, 2021 and is designated Class II. Reason for recall: Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced) The recall status is terminated (terminated July 28, 2022). Affected quantity: 77 kits.
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- September 3, 2021
- Termination Date
- July 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77 kits
Product Description
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Reason for Recall
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
Code Information
Lot Number: 2104321637 Unique Identifier: 00840118112079